The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Pressure Catheter Placement Set 50010.
Device ID | K841482 |
510k Number | K841482 |
Device Name: | PRESSURE CATHETER PLACEMENT SET 50010 |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | DLP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-09 |
Decision Date | 1984-06-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994654069 | K841482 | 000 |
20613994679745 | K841482 | 000 |
20613994679738 | K841482 | 000 |
20613994654056 | K841482 | 000 |